The present invention relates to devices, systems, and treatment methods directed at aligning and correcting orthodontic or dentofacial and/or mild craniofacial variations, including both foundational correction (a treatment that changes the skeletal and/or dental tissues) and functional correction (a treatment that changes the soft tissues and/or tissue spaces).
More specifically, the present invention relates to clinical protocols, devices, systems, and methods incorporating osteogenetic-pneumopedic and/or osteogenetic-orthodontic appliances. Osteogenetic-pneumopedic and osteogenetic-orthodontic appliances are specialized orthopedic and/or orthodontic appliances that signal the genome of the patient to non-surgically remodel tissues and spaces, for example via a patient's own, inherent stem cells. Osteogenetic-pneumopedic treatment provides an integrated patient management system using a multi-disciplinary approach, incorporating devices, systems, and methods directed at aligning and correcting orthodontic, dentofacial and/or mild craniofacial variations, using both foundational correction and functional correction, including non-surgical airway-remodeling.
The cranio-caudal gradient of human development theory teaches that the cranium develops before the midface, which develops before the mandible etc. Current and existing treatment methods and appliances teach the use of compartmentalized patient management. And, specifically, the current art teaches that common craniofacial abnormalities are suitably corrected by using well-known devices and treatment methods that include surgery, injections and drugs.
Common orthodontic, dentofacial and craniofacial abnormalities are typically corrected for both esthetic and medical reasons. Reasons include, for example, the perception that a well-balanced face is beautiful and correlates with minimal or no craniofacial health problems. Common health problems associated with unbalanced, unhealthy faces include, for example: Deformational or positional plaigocephaly; mouth-breathing; dental malocclusions; bruxism (including, grinding, clenching and tooth wear); facial underdevelopment (including facial asymmetry and craniofacial obesity); temporo-mandibular joint dysfunction (TMD); and upper airway difficulties and sleep disordered breathing, such as snoring, upper airway resistance syndrome and obstructive sleep apnea (OSA). These conditions, whether diagnosed or covert, represent major issues in this field of work. In addition, a well-balanced face may be more resistant to head injury, such as concussion or mild traumatic brain injury, either during sport or in other physical activities.
Although traditional devices and treatments attempt to correct the esthetic problems, they do not adequately address underlying causes of poor craniofacial homeostasis. Poor craniofacial homeostasis is commonly accompanied by several other clinically observable signs and symptoms, such as cranial asymmetry and facial asymmetry, airway issues etc., according to the patient's genome.
For example, one major issue not adequately addressed in the current art teachings and traditional methods and devices is the irregular alignment of the cranium, jaws and teeth as a result of development compensation. For example, malocclusion, an obvious sign of which is irregular teeth, belies a more serious issue, and may require correction of the soft tissues (e.g. the tongue) and/or development of the bone constituting the cranium, including the jaws, during comprehensive, integrated, multi-disciplinary care.
Further, the current teachings in this art do not fully treat the underlying causes of developmental compensation. The current art does not provide treatment methods or devices that adequately interact with or naturally-manipulate the patient's genome via stem cells. Due to an overall lack of recognizing the importance of the impact of the environment acting on a patient's genes, traditional methods and devices lack structural elements and clinical protocols necessary to properly signal or interact more appropriately with a patient's genes via stem cells. This results in less than optimal corrections despite the current-art's attempt at invoking temporo-spatial patterning or the genetic template of craniofacial development.
Examples of common but detrimental environmental stimuli not properly addressed by the current art include: Postural influences, such as excessive laying down of a newborn baby on its back, deficient holding of a baby/infant, or excessive baby/infant car seat use; and Myofunctional influences, such as a lack of breast-feeding, bottle-feeding, pacifier use, digit-sucking, or other childhood habits, including a soft diet of refined foods.
Other genome-related and environmental-influenced abnormalities not adequately addressed in the current art include certain features of deformity, such as cranial asymmetry, and dysfunctional features, including adverse tongue posture, abnormal swallowing patterns and lip activity, which lead to further craniofacial consequences as the child matures. One further craniofacial consequence during maturation includes malocclusion. Additionally, some consequences, for example obstructive sleep apnea or a predisposition to concussion, may not manifest until early or late adulthood.
These aforementioned consequences are the outcomes of gene-environmental interaction factors that—according to recent studies—perturb the genetic, craniofacial foundation encoded by genes. The perturbed features include cranial asymmetry, a high-vaulted palate with maloccluded teeth, and other dysfunctional features, such as a submandibular pannus (double chin) or unerupted wisdom teeth, etc. Further, the complexity of these gene-environmental interactions leads to heterogeneity. Thus, a given patient may present a single feature such as a lisp, malocclusion, TMD, snoring, wear facets on teeth, aged facial appearance or any combination of the above, even though the underlying etiology is similar.
According to the teaching of the current state-of-the art, these perturbed features and abnormalities are well adapted to corrective treatments, for example using appliances that utilize biomechanical loading. Biomechanical loading, as taught by the current state-of-the-art, is an important regulator of osteogenesis. Osteogenesis recognizes that bone formation occurs in response to its functional environment and, accordingly, biomechanical loading using biophysical techniques of osteo-stimulation can be successful when used in a clinical practice. These clinical, biophysical techniques include surgical, craniofacial distraction osteogenesis, and the application of ultrasound to promote bone formation, for example.
Sutures, another known structure adapted to correct craniofacial features and abnormalities in the current art, are fibrous connective tissue articulations found between intramembranous craniofacial bones. They consist of multiple connective tissue cell lines such as mesenchymal cells, fibroblasts, osteoclasts and osteogenic cells derived from stem cells. Sutures are organized with stem cells. For example, osteogenic cells differentiate at the periphery, producing a matrix that is mineralized during bone growth and development; fibroblastic cells are found with their matrices in the center.
Cyclic loading of sutures has clinical implications and act as mechanical stimuli for modulating craniofacial growth and development in patients. One study demonstrated that in vivo mechanical forces regulate sutural growth responses in rats. In that study, cyclic compressive forces of 300 mN at 4 Hz were applied to the maxilla for 20 min/day over 5 consecutive days. In that study, computerized analysis revealed that cyclic loading significantly increased the average widths of the sutures studied in comparison with matched controls, and the amount of osteoblast-occupied sutural bone surface was significantly greater in cyclically loaded sutures.
Thus, studies demonstrate that cyclic forces are potent stimuli for modulating postnatal sutural development, potentially by stimulating both bone formation (osteogenesis) and remodeling (osteoclastogenesis). Therefore, craniofacial sutures have capacities for mechanical deformation, and the elastic properties of sutures may potentially play a useful role in improving the craniofacial health of a patient through continued craniofacial development via stem cells.
Current data on suture mechanics suggest that mechanical forces regulate sutural growth by inducing sutural mechanical strain. Therefore, various therapies, including osteogenetic-pneumopedic and/or osteogenetic-orthodontic appliances, may induce sutural strain, leading to modifications of natural sutural growth. For example, Singh G. D., Diaz, J., Busquets-Vaello, C., and Belfor, T. R. in “Soft tissue facial changes following treatment with a removable orthodontic appliance in adults,” Funct. Orthod., (2004) vol. 21 no. 3 at pp. 18-23, reported dental and facial changes in adults treated with a rigid, static, removable orthodontic appliance (and as disclosed in U.S. Patent Application No. 2007/0264605 published on 15 Nov. 2007, and as disclosed in U.S. Pat. Nos. 7,314,372 issued on 1 Jan. 2008 and 7,357,635 issued on 15 Apr. 2008, the full disclosures of which are hereby incorporated by reference as if set out fully herein). Furthermore, Singh G. D., Garcia A. V. and Hang W. M. in “Evaluation of the posterior airway space following Biobloc therapy: Geometric morphometrics” in the Journal of Craniomandibular Practice 25(2): 84-89, 2007, reported non-surgical airway remodeling in children treated with a rigid, static, removable orthodontic protocol. A relative 31% increase in nasopharyngeal airway area was found above and behind the soft palate. Additionally, a 23% increase in oropharyngeal airway area was located behind the base of the tongue, with a 9% increase in hypopharyngeal area near the level of the hyoid bone. Thus, functional airway improvements i.e. a pneumopedic effect is/are associated with removable orthodontic protocols in actively growing children. However, the treatment time in children was excessively long (up to 27 months) using that rigid, static, removable orthodontic protocol. Nevertheless, current orthodontic and dentofacial orthopedic therapies exclusively utilize static forces to change the shape of craniofacial bones via mechanically-induced bone apposition and resorption, but cyclic forces capable of inducing different sutural strain wave forms may accelerate sutural anabolic or catabolic responses via stem cells.
Recently, it was shown that low-intensity, pulsed ultrasound enhances jaw growth in primates when combined with a mandibular appliance, and that orthodontically induced root resorption can be repaired using ultrasound in humans.
Yet, there remains a need for improved treatment methods, systems, and devices that utilize therapies that harness the underlying developmental mechanisms—encoded at the level of the gene and realized via stem cells. Further, such improved treatment methods, devices, and systems should utilize the application of brief doses of cyclic forces to induce sutural osteogenesis via stem cells. Additionally, there remains a need for removable, non-rigid, osteogenetic-pneumopedic and/or osteogenetic-orthodontic appliances with cyclic functionality and a system and method to bioengineer vibrational osteogenetic-pneumopedic and/or osteogenetic-orthodontic devices. However, for any foundational correction to remain stable, it must be co-provided with a functional correction.